New Delhi, February 15
Following more than 2,200 deaths in clinical trials in the past five years, the government has finally set up four expert committees to streamline approvals and evolve standard operating procedures for marketing of drugs in India, which are discovered abroad.

The move comes following Supreme Court's observation that the Ministry of Health was watching meekly as the unregulated clinical trial sector played "havoc" with the people. The committees will also address issues related to lack of regulation in the drug sector which the Parliamentary Standing Committee on Health had raised in 2012 report. The committee had revealed how the ministry was allowing foreign made drugs (banned abroad) to be sold in India against the provisions of the Drugs and Cosmetics Act Procedures.

The ministry has now set up an apex committee under the chairmanship of the health secretary which will meet every month to "take stock of new approvals". This committee will be assisted by a 15-member technical panel comprising among others former MCI BoG member Ranjit Roy Choudhary, Vinod Raina of AIIMS, Jaspal Sharma of Chandigarh PGI and Debasis Basu of Kolkata Medical College.

"The technical committee will meet monthly to oversee the conduct of clinical trials in India and give its recommendations to the apex committee. The list of clinical trials, their titles and objective of the study and name of the applicant, permitted to hold clinical trial by the Drug Controller General of India, will be submitted to the Technical Committee on a monthly basis from now on," the ministry order says.

Importantly, the government has woken up to the need of guidelines to approve new drugs for marketing in India and ban drugs once more efficacious ones hit the markets. Two expert committees under Choudhary and Prof CL Kolkate, V-C, KLE University, Belgaum, will draft SOPs to approve new drugs (manufactured abroad) in India and fixed dose combinations and also list conditions wherein local clinical trials of such drugs would be necessary and those where such trials can be relaxed.

Between 2001 and 2010, the DCGI had approved 2,167 new drugs manufactured outside India for marketing in India. Of these, the parliamentary committee had selected 2 per cent, 42 drugs, to examine if rules were followed. The ministry could not provide documentation for three banned drugs which the West never allowed marketing permission (Pefloxacin, Iomefloxacin and Sparofloxacin). These drugs continued to be sold in India.

Of the 39 drugs whose documentations was available, 13 being sold in India had no marketing permission in the West and none (among them buxlizine, an appetite stimulant; nimuselid injection; FDC of Ofloxacin with Ornodazole) had any relevance to India. Almost 11 drugs, including Everolimus of Novartis; Colistimethate of Cipla and Exemestane of Pharmacia, were being sold without mandatory Phase III clinical trials on Indians.

In 25 drugs (64 per cent), expert opinion was never sought before approval and in case of 14, only three experts were consulted; this when the West consulted 25 experts simply to debate the dose requirement for paracetamol.

DRUG TRIALS

The move comes following Supreme Court’s observation that the Ministry of Health was watching meekly as the unregulated clinical trial sector played ‘havoc’ with the people

Between 2001 and 2010, the DCGI had approved 2,167 new drugs manufactured outside India for marketing in India. Of these, the parliamentary committee had selected 2%, 42 drugs, to examine if rules were followed

The ministry failed to provide documentation for three banned drugs, which the West never allowed marketing permission

The government has finally woken up to the need of guidelines to approve new drugs for marketing in India and ban drugs once more efficacious ones hit the market

An apex committee under the health secretary will meet every month to monitor all ongoing drug trials